Documentation Specialist I

Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Documentation Specialist I , working in Biotechnology/Medical Devices industry in 1 Research Drive, Westborough, Massachusetts, 01581, United States . Job description: Manage product complaints. Review and release production batch records. Review manage change controls. Providing Quality Review and approval of deviations related to Manufacturing Equipment, Facility and production. Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution. Report metrics and create monthly and quarterly reports. Develop Sops as required. Performs in accordance with SOPs, safety and GMP guidelines to support release of finished product. Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group to develop organizational and technical capabilities. Be current with various regulatory requirements and procedures. Our Client Our client is an award-winning clinical development company. Improving lives globally with 20 years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models. Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work. Experience Required for Your Success Requirements: 2-3 years of experience working in a CGMP environment Experience working in Quality in a GMP environment Experience working in a Quality role supporting production Experience with technical writing Ability to operate in an environment with strict timelines Experience performing work that consistently requires decision making and the exercise of judgment and discretion in a CGMP environment Experience demonstrating written and verbal communication skills Experience demonstrating proficiency with Microsoft Office applications Education: BS/BA degree in a scientific discipline. A combination of education, training and experience may be considered in lieu of the above stated qualifications What Do You Think? Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?

Created: 2024-10-28